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Jentadueto xr

Generic Name: linagliptin and metformin> (LIN a GLIP tin and met FOR min)
Brand Names: Jentadueto
Jentadueto (linagliptin and metformin) is used to treat type 2 diabetes. Includes Jentadueto side effects, interactions and indications.
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Drug Information:
Jentadueto contains a combination of linagliptin and metformin. Linagliptin and metformin are oral diabetes medicines that help control blood sugar levels. Metformin works by decreasing Glucose (sugar) production in the liver and decreasing absorption of Glucose by the intestines. Linagliptin works by regulating the levels of insulin your body produces after eating. Jentadueto is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. Jentadueto is not for treating type 1 diabetes. Learn more

Jentadueto xr Side Effects

Jentadueto Side Effects

Note: This document contains side effect information about linagliptin / metformin. Some of the dosage forms listed on this page may not apply to the brand name Jentadueto.

In Summary

Common side effects of Jentadueto include: lactic acidosis and hypoglycemia. Other side effects include: decreased vitamin b12 serum concentrate. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to linagliptin/metformin: oral tablet, oral tablet extended release

Warning

Oral route (Tablet; Tablet, Extended Release)

Lactic acidosis can occur due to metformin accumulation during treatment with linagliptin / metformin hydrochloride, and case reports of death, hypothermia, hypotension, and resistant bradyarrhythmias have been reported. The risk of lactic acidosis is increased with renal impairment, concomitant cationic drugs (eg, topiramate), age 65 years or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (eg, acute congestive heart failure), excessive alcohol intake, and hepatic impairment. Onset is often subtle with symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Laboratory abnormalities include elevated blood lactate levels (greater than 5 mmol/L), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate/pyruvate ratio, and metformin plasma levels generally greater than 5 mcg/mL. If lactic acidosis is suspected, immediately discontinue therapy, hospitalize patient, and promptly start hemodialysis.

Along with its needed effects, linagliptin / metformin may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking linagliptin / metformin:

Less common

  • Anxiety
  • blurred vision
  • chills
  • cold sweats
  • confusion
  • cool, pale skin
  • depression
  • dizziness
  • fast heartbeat
  • headache
  • increased hunger
  • loss of consciousness
  • nausea
  • nightmares
  • seizures
  • shakiness
  • slurred speech
  • unusual tiredness or weakness

Incidence not known

  • Bloating
  • constipation
  • darkened urine
  • fainting spells
  • fever
  • indigestion
  • irregular heartbeat
  • large, hard skin blisters
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • loss of appetite
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • severe joint pain
  • vomiting
  • yellow eyes or skin

Some side effects of linagliptin / metformin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Diarrhea
  • excess air or gas in the stomach or intestines
  • feeling of fullness
  • heartburn
  • lack or loss of strength
  • muscle aches
  • passing gas
  • sore throat
  • stuffy or runny nose

Incidence not known

  • Cough
  • decreased appetite
  • difficulty with moving
  • flaking and falling off of the skin
  • hives or welts, itching, or skin rash
  • muscle aching or cramping
  • muscle pains or stiffness
  • redness of the skin
  • swollen joints

For Healthcare Professionals

Applies to linagliptin / metformin: oral tablet, oral tablet extended release

General

The most commonly reported adverse events included nasopharyngitis and diarrhea.

Metabolic

Linagliptin-Metformin:

Frequency not reported: Hypoglycemia

Linagliptin:

Common (1% to 10%): Hypertriglyceridemia, hyperlipidemia, weight increased

Metformin:

Very rare (less than 0.01%): Lactic acidosis, vitamin B12 deficiency

Hypoglycemia was more commonly reported in patients receiving the combination linagliptin / metformin plus a sulfonylurea compared with those receiving metformin plus a sulfonylurea (22.9% vs 14.8%; n=792).

Gastrointestinal

Gastrointestinal events such as nausea, vomiting, diarrhea, decreased appetite, and abdominal pain occur most frequently during initiation of therapy and resolve spontaneously in most cases.

During clinical trials, pancreatitis was reported in 15.2 cases per 10,000 patient year exposure in patients receiving linagliptin compared with 3.7 cases per 10,000 patient year exposure in those receiving active comparator (sulfonylurea). Following completion of clinical trials, 3 additional cases of pancreatitis were reported among those receiving linagliptin. Postmarketing reports of acute pancreatitis, including fatalities, have been received.

Linagliptin-Metformin:

Common (1% to 10%): Decreased appetite, diarrhea, nausea, vomiting

Uncommon (0.1% to 1%): Increased blood amylase

Postmarketing reports: Mouth ulceration

Linagliptin:

Common (1% to 10%): Constipation, diarrhea

Frequency not reported: Pancreatitis

Metformin:

Very common (10% or more): Diarrhea, nausea, vomiting, abdominal pain, decreased appetite

Common (1% to 10%): Constipation

Frequency not reported: Flatulence, indigestion

Hypersensitivity

Linagliptin-Metformin:

Rare (less than 0.1%): Drug hypersensitivity

Linagliptin

Postmarketing reports: Serious hypersensitivity reactions

Serious hypersensitivity reactions including anaphylaxis, angioedema, and exfoliative skin conditions have been reported postmarketing in patients treated with linagliptin. These reactions have occurred within the first 3 months, with some occurring after the first dose.

Respiratory

Linagliptin-Metformin

Common (1% to 10%): Nasopharyngitis (6.3%),

Uncommon (0.1% to 1%): Cough

Linagliptin

Common (1% to 10%): Nasopharyngitis, cough

Metformin

Common (1% to 10%): Nasopharyngitis

Dermatologic

Postmarketing reports of bullous pemphigoid requiring hospitalization have been reported with dipeptidyl peptidase-4 (DPP-4) inhibitors use. These case typically recovered with topical or systemic immunosuppressive treatment and discontinuation of DPP-4 inhibitor.

Linagliptin-Metformin:

Uncommon (0.1% to 1%): Pruritus

Postmarketing reports: Angioedema, urticaria, rash

Metformin:

Very rare (less than 0.01%): Skin reactions such as erythema, pruritus, and urticaria

Dipeptidyl peptidase-4 inhibitors:

Postmarketing reports: Bullous pemphigoid

Hematologic

Metformin

Very rare (less than 0.01%): Megaloblastic anemia

Hepatic

Metformin:

Very rare (less than 0.01%): Hepatitis, liver function test abnormalities

Musculoskeletal

Linagliptin:

Frequency not reported: Myalgia, arthralgia

Between October 2006 and December 2013, thirty-three cases of severe arthralgia have been reported to the FDA Adverse Event Reporting System Database. Each case involved the use of 1 or more dipeptidyl peptidase-4 (DPP-4) inhibitor. In all cases, substantial reduction in prior activity level was reported, 10 patients were hospitalized due to disabling joint pain. In 22 cases, symptoms appeared within 1 month of starting therapy, in 23 cases symptoms resolved less than 1 month after discontinuation. A positive rechallenge was reported in 8 cases, with 6 cases involving use of a different DPP-4 inhibitor. Sitagliptin had the greatest number of cases reported (n=28) followed by saxagliptin (n=5), linagliptin (n=2), alogliptin (n=1), and vildagliptin (n=2).

Nervous system

Metformin:

Common (1% to 10%): Taste disturbance

Genitourinary

Linagliptin:

Common (1% to 10%): Urinary tract infection,

Psychiatric

Linagliptin:

Common (1% to 10%): Headache

Metformin:

Common (1% to 10%): Headache

Editorial References and Review

Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.

Source: Drugs.com Jentadueto Xr (www.drugs.com/jentadueto.html).